MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; CV BYPASS PACK

Model Number DYNJ44932N

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/21/2022

Event Type  Injury  

Event Description

According to the customer, on (b)(6) 2022 when using the 'hall saw in the or the blade broke when trying to use it to open the chest'.

Manufacturer Narrative

According to the customer, on (b)(6) 2022 when using the 'hall saw in the or the blade broke when trying to use it to open the chest'.The customer reported the product 'broke off in the bone of the sternum, the procedure was stopped, the patients lungs were re-inflated, the product was removed, and a new product was obtained'.The customer reported that there was no harm that occurred to the patient.The sample is available but has not been returned for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Type of Device: CV BYPASS PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15959195
• MDR Text Key: 305257077
• Report Number: 1423395-2022-00044
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10193489911060
• UDI-Public: 10193489911060
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ44932N
• Device Catalogue Number: DYNJ44932N
• Device Lot Number: 22HBX830
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention